PROJECT SUMMARY: DESIGN, EPIDEMIOLOGY, AND BIOSTATISTICS CORE The overall goal of the Clinical Research Design, Epidemiology, and Biostatistics Key Component Activity (DEB KCA) of the Louisiana Clinical and Translational Science Center (LA CaTS) is to ensure that all clinical and translational research conducted within the LA CaTS purview meets the highest scientific standards for study design and analysis. During the initial funding period, we successfully leveraged existing DEB expertise from the faculties of the Primary Collaborating Institutions and implemented an integrated DEB support network that is now available to investigators at all participating LA CaTS institutions. We now provide DEB services and consultation to COBRE/INBRE mentees across the state, to our Roadmap and Meritorious scholars, and to other investigators seeking to expand their research toward translational efforts. To meet the needs for additional bioinformatics expertise, the DEB KCA director led the creation of the Southeast Informatics Consortium (SIC) to identify specific requirements, formulate ways to share resources and work together to advance the use of bioinformatics in clinical and translational research. The LA CATS leadership, and their respective institutions, provided considerable resources enabling the DEB KCA to expand our biostatistics capacity, add additional epidemiology expertise, and provide unique proficiency in bioinformatics approaches. We are a comprehensive DEB resource for LA CaTS investigators and we offer one of the most requested services within the LA CaTS Center. Aim 1. Enhance and expand the DEB KCA by developing and implementing strategic study designs, emphasizing rigor, reproducibility, validity, and sustainability of our findings. This will be accomplished using appropriate controls and comparison conditions, reducing bias, and increasing study power efficiency followed by deploying state-of-the-art data analyses, objective and transparent interpretation of research findings, publishing new discoveries, and seeking funding to support the next steps in our research pursuits. Aim 2. Create and implement novel statistical analytics, inferential and modeling solutions in data mining, precision medicine and molecular epidemiology in addition to more traditional experimental and observational research with strong emphasis on special Louisiana cohorts. Aim 3. Promote and deliver professional development by providing educational opportunities for faculty, trainees, and research staff. Thus, the DEB KCA strives to justify clinical and translational research conclusions through rigorous pursuit and objective interpretation of investigative findings within a well-established infrastructure for arriving at sustainable inferential conclusions.